K-RECRUITING Life Sciences Personalberatung - flip image

Tasks:

Provides clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
Lead development of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
Drives execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates if applicable
Oversees/conducts ongoing medical and scientific review of clinical trial data with Clincal Scientific Expert(s)
May be the Program Manager of other associates (e.g.., CSE).
May act as study medical monitor
Supports (Sr.) Global Program Clinical Headin ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety
Supports the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the TAH
As a medical expert, supports the (Sr.) GPCH or TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards

K-RECRUITING Life Sciences Personalberatung - box background image

Qualifications:

Start: 01.05.2021 // Duration: 5 months + // Capacity: 40 h/week
MD or equivalent medical degree required
Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required, with Medical Board certification
Over 4 years of Clinical practice experience (including residency)
Experience in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV
Advanced knowledge in the field of Oncology (Breast Cancer)
Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/ clinical development process

Clinical Development Medical Director - Breast Cancer

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